Z-1174-2012

Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification

Name: Z-1174-2012 Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification
Creator: Beckman Coulter Inc.
Published: 2009-08-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-08-11 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when... on 2009-08-11. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1174-2012
Status: Terminated
Initiated: 2009-08-11
Posted: 2012-03-06
Terminated: 2013-12-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.
Product code: DKB Calibrators, Drug Mixture
Reason for recall: The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 26, 2009 to all customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Customers were asked to complete and return a response form. Contact Beckman Coulter Customer Support Center (Hotline) at (800) 854-3633 for questions regarding this recall.
Quantity in commerce: 31,559 units total (30,617 units in the US)
Distribution: Worldwide Distribution--USA (nationwide) and the country of Canada.
Product codes and lots: M810083 and earlier

Product code DKB

K955644Class IISynchron Systems Carbamazepine Test SystemBeckman Instruments, Inc. / cleared 1996-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)